Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
Primary Purpose
PONV
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcutaneous electrical acupoint stimulation
Sponsored by
About this trial
This is an interventional prevention trial for PONV focused on measuring transcutaneous electrical acupoint stimulation, liver surgery
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years
- scheduled for elective liver surgery under general anesthesia
Exclusion Criteria:
- body mass index less than 18 kg/m2 or higher than 30 kg/m2
- American Society of Anesthesiologists status higher than Ⅲ
- patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
- suspected or existed abuse of drug or alcohol
- pregnant or breeding women
- history of neurological or psychiatric disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
transcutaneous electrical acupoint stimulation
Control
Arm Description
Outcomes
Primary Outcome Measures
incidence of nausea and vomiting by 24 hours after surgery
Secondary Outcome Measures
incidence of nausea and vomiting by 48 hours after surgery
incidence of nausea and vomiting in PACU (post-anesthesia care unit)
score of nausea and vomiting by 24 hours after surgery
score of nausea and vomiting by 48 hours after surgery
score of nausea and vomiting in PACU(post-anesthesia care unit)
Quality of recovery score at 24 hours after surgery
Quality of recovery score at 48 hours after surgery
postoperative in-hospital stay
death by 6 months after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05396716
Brief Title
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
Official Title
Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2022 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhihong LU
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PONV
Keywords
transcutaneous electrical acupoint stimulation, liver surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The stimulator is put in an opaque box
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcutaneous electrical acupoint stimulation
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
TEAS
Intervention Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Primary Outcome Measure Information:
Title
incidence of nausea and vomiting by 24 hours after surgery
Time Frame
from end of surgery to 24 hours after surgery, in a total of 24 hours
Secondary Outcome Measure Information:
Title
incidence of nausea and vomiting by 48 hours after surgery
Time Frame
from end of surgery to 48 hours after surgery, in a total of 48 hours
Title
incidence of nausea and vomiting in PACU (post-anesthesia care unit)
Time Frame
from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
Title
score of nausea and vomiting by 24 hours after surgery
Time Frame
from end of surgery to 24 hours after surgery, in a total of 24 hours
Title
score of nausea and vomiting by 48 hours after surgery
Time Frame
from end of surgery to 48 hours after surgery, in a total of 48 hours
Title
score of nausea and vomiting in PACU(post-anesthesia care unit)
Time Frame
from end of surgery to discharge from PACU, in an average of 30 minutes
Title
Quality of recovery score at 24 hours after surgery
Time Frame
from end of surgery to 24 hours after surgery, in a total of 24 hours
Title
Quality of recovery score at 48 hours after surgery
Time Frame
from end of surgery to 48 hours after surgery, in a total of 48 hours
Title
postoperative in-hospital stay
Time Frame
from end of surgery to discharge from hospital, in an average of 7 days
Title
death by 6 months after surgery
Time Frame
from end of surgery to 6 months after surgery, in a total of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥18 years
scheduled for elective liver surgery under general anesthesia
Exclusion Criteria:
body mass index less than 18 kg/m2 or higher than 30 kg/m2
American Society of Anesthesiologists status higher than Ⅲ
patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
suspected or existed abuse of drug or alcohol
pregnant or breeding women
history of neurological or psychiatric disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Lu
Phone
+8613891975018
Email
deerlu23@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shan He
Phone
8684775343
Email
1411950442@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26522652
Citation
Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
Results Reference
background
Learn more about this trial
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
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